On February 3, 4 and 8, 2010, the Food and Drug Administration (FDA) inspected your food manufacturing firm located at 677 Anita St., Suite F Chula Vista, CA. During the inspection, FDA investigators documented numerous significant violations of the Current Good Manufacturing Practice (CGMP) regulation for foods, Title 21, Code of Federal Regulations, Part 110 (21 CFR 110). These violations were listed on the Inspectional Observations, Form FDA 483 (FDA-483) given to you at the close of the inspection. These conditions cause food products manufactured in your firm to be adulterated within the meaning of Section 402(a)(4) of the Federal Food, Drug, and Cosmetic Act (the Act), 21 U.S.C. § 342(a)(4), in that they have been prepared, packed, or held under insanitary conditions whereby they may have been contaminated with filth or rendered injurious to health. You can find links to the Act and regulations at FDA's website at www.fda.gov.

The following deficiencies were observed by the investigator during the inspection:

1. Employees did not wash hands thoroughly in an adequate hand-washing facility before starting work, after each absence from the work station, and at any other time when the hands may have become soiled or contaminated [21 CFR 110.10(b)(3)]. Specifically, on February 3, 2010, the inspector observed the following:

•A female employee working finishing cheesecake took off her disposable gloves and put them in her apron pocket to move around boxes and miscellaneous items inside the room. She then put back on the same pair of gloves without first washing her hands. The disposable gloves had visible food residue on them.

•A male employee was observed moving containers containing cake pans while wearing gloves. The containers had dried food residue and grease on the handles and exterior. He then began assembling cheesecakes making graham cracker cheesecake crust and pouring cheesecake batter into cake pans. He was wearing the same pair of gloves.

•A male employee was observed handling unclean pans and utensils while wearing disposable gloves. The employee then began handling clean pans and utensils and cleaning a food preparation table while wearing the same gloves. He did not change gloves between handling the unclean and the clean items.

2. Failure to handle work-in-progress in a manner that protects against contamination [21 CFR 110.80(b)(5)]. Specifically,

•On February 3, 2010, uncovered in-process carrot cakes that were baked and ready to eat were stored on carts and on racks inside of the cooler. Buckets covered with black, grey and green mold were stored directly above, below and immediately adjacent to the uncovered cakes. In addition, mold was observed on surfaces throughout the cooler including on racks where raw ingredients were stored located at the opposite end of the cooler.

•In addition, condensate from overhead condensing units was observed to have dripped onto and frozen on top of cases of finished product stored in the freezer on the north wall of the facility.

3. Failure to manufacture foods under such conditions and controls as are necessary to minimize the potential for the growth of microorganisms, or for the contamination of food [21 CFR 110.80(b)(2)]. Specifically,

• Your firm is manufacturing butter cream icing and cream cheese icing. These icings contain dairy products such as cream cheese and butter that are subject to pathogen growth and toxin formation if subjected to prolonged and elevated time/temperature exposures. On February 3, 2010, at 10:30 AM, the investigator measured the temperature of two 5 gallon buckets containing butter cream icing and cream cheese icing at 64°F. At 4:30 PM, he returned and measured the temperature to again be at 64°F. Employees were continuing to use the icing after the second temperature reading.

•An unidentified sticky substance was observed on control panels to mixers and the oven, and on carts and baskets used to hold baking pans.

•On February 3, 2010, the investigator measured the concentration of the sanitizer that was in use at the three-compartment warewashing sink and found there was no measurable residual of quaternary ammonium in the sanitizing water solution. The chemical container was replaced at that time and the sink compartment was refilled. The new solution tested at 200 ppm. The investigator returned a few hours later and found the solution had not been changed during use and the concentration had dropped to below 50 ppm, which is below the stated minimum concentrations listed on the label for sanitizing food contact equipment.

•An employee in the cake finishing room was cleaning food preparation tables with a rag and a bucket filled with murky water with visible food residue. The employee stated that there was a bleach sanitizer in the water. However, the investigator's test of the solution found there to be no measurable residual chlorine in the solution.

6. Failure to clean and sanitize utensils and equipment in a manner that protects against contamination of food or food contact surfaces [21 CFR 110.35(a)]. Specifically,

• Employees were observed cleaning pastry bags used for icing cakes, small bowls and utensils in the hand washing sink in the finishing room.

• The freezer door on the freezer located along the north wall at the rear of the facility did not seal properly.

• On February 3, 2010, frozen condensate was observed covering the ceiling of the freezer and the fixtures inside the freezer such as the condenser fans, lighting and piping.

8. Employees were observed to be drinking beverages in areas where food is exposed [21 CFR 110.10(b)(8)]. Specifically, employees were observed drinking coffee at food preparation areas including at the batter filling table and inside the cake finishing room where icing and
decorations are put onto finished ready to eat cakes.

9. Personal belongings were stored in an area where equipment or utensils are washed [21 CFR 110.10(b)(7)]. Specifically, unclean personal dishes including cups and a bowl were stored on top of the warewashing sink along with cake pans and other food manufacturing utensils.

10. Effective measures were not being taken to exclude pests from the processing areas [21 CFR 110.35(c)]. Specifically, approximately a dozen fruit flies were observed flying around used cake pans in the warewashing and oven areas.

11. The disposal of rubbish did not minimize the development of odor and potential for waste becoming an attractant and harborage or breeding place for pests [21 CFR 110.37(0]. Specifically, trash from food manufacturing was observed stacked a couple of feet above the rim of the dumpster and was spilling out onto the ground below. In addition, there was spilled food observed around the general vicinity of the dumpster area at the rear of the facility.

12. The plumbing was not adequately installed to avoid constituting a source of contamination to water supplies [21 CFR 110.37(b)(3)]. Specifically, a hose with a trigger nozzle was observed attached to a mop sink faucet. The mop sink faucet has a hose bib vacuum breaker attached to it which does not provide protection from backflow under the conditions of use.

13. Lack of a sanitary towel service or suitable hand drying devices [21 CFR 110.37(e)(3)]. Specifically, on February 3-4, 2010, there were no paper towels or other form of hand drying device located at the hand washing sink at the entrance of the facility.

14. Toxic materials that are not required to maintain clean and sanitary conditions, are unnecessary for plant and equipment maintenance, and are unnecessary for use in plant operations, were nonetheless stored in your facility [21 CFR 110.35(b)(1)]. Specifically, on February 4, 2010, the investigator observed a container of charcoal lighter fluid under a production table inside the cake finishing room.

Furthermore, your food film is not registered as required by Section 415 of the Act, 21 U.S.C. § 350d, and 21 CFR 1.225.

We received your FDA-483 response dated February 26, 2010, which mainly consisted of photographs showing cleaning and repairs within your facility, some of which were initiated at the time of the inspection. FDA will evaluate and verify these corrections during the next inspection. Although your response appears to correct some of the deficiencies listed in the FDA-483, it did not address corrections to your employee practices.

This letter is not intended to be an all-inclusive list of the violations at your facility. It is your responsibility to ensure compliance with applicable laws and regulations administered by FDA. You should investigate and determine the causes of the violations and take prompt actions to correct the violations to bring your products into compliance. Failure to promptly correct these violations may result in legal action without further notice including seizure and injunction.

Please notify this office in writing within fifteen (I5) working days from the date you receive this letter of the specific steps you have taken to correct the noted violations, including an explanation of how you plan to prevent these violations, or similar violations, from occurring

again. Include documentation of the corrective action you have taken. If your planned corrections will occur over time, please include a timetable for implementation of those corrections. If corrective action cannot be completed within 15 working days, state the reason for the delay and the time within which the corrections will be completed.